Merck Gets CHMP Backing of Keytruda in Gastrointestinal Cancer
May 24 2021 - 6:21AM
Dow Jones News
By Colin Kellaher
Merck & Co. Monday said the European Medicines Agency's
Committee for Medicinal Products for Human Use recommended expanded
approval of its blockbuster cancer drug Keytruda in certain types
of gastrointestinal cancers.
The Kenilworth, N.J., drugmaker said the recommendation covers
Keytruda in combination with platinum- and fluoropyrimidine-based
chemotherapy for the first-line treatment of patients with locally
advanced unresectable or metastatic carcinoma of the esophagus or
HER2-negative gastroesophageal junction adenocarcinoma in adults
whose tumors express PD-L1 (CPS >=10).
Merck said the positive CHMP opinion is based on results from
the a phase 3 study in which Keytruda plus 5-fluorouracil and
cisplatin showed significant improvements in overall survival and
progression-free survival compared with 5-FU and cisplatin alone in
patients regardless of histology or PD-L1 expression status.
The European Commission, which generally follows the CHMP's
advice, is expected to make a decision in the second quarter, Merck
said.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 24, 2021 07:14 ET (11:14 GMT)
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